It is a sensitive topic, isn’t it? When it comes to children, special rules applies. That is why all (EU) institutions – without any exceptions – are obliged to increase the transparency of procedures for ensuring that children can benefit from medicines.
In order to protect better the health of children, the EU adopted a Paediatric Regulation in 2006. The Regulation includes an obligation requiring pharmaceutical companies to conduct tests to determine whether and how their medicines can be used to treat children. European Medicines Agency (EMA) is responsible for ensuring that pharmaceutical companies comply with their obligations under the Paediatric Regulation.
In October 2009, two pharmaceutical companies lodged a complaint with the the European Ombudsman because EMA was obliging them to test how their heart failure medicine could be used to treat children. They alleged discrimination, since EMA had exempted two similar medicines from the requirement to be subjected to such tests.
EMA stated that the limited number of children suffering from heart failure meant that only one heart failure medicine could be tested effectively. According to EMA, the complainants' medicine was the most promising, and thus the most appropriate medicine to test.
The Ombudsman conducted an investigation into the assessment procedures for the different medicines. He came to the conclusion that EMA was indeed entitled to oblige the complainants to conduct the tests. However, he criticised EMA's failure to ensure adequate transparency in its decision-making process. He called on EMA to document fully and disclose its assessments in the future and also to introduce relevant guidelines in this respect. He asked EMA to reply to his recommendation by 30 September 2012.